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FDA 510(k)

SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM

K-Number: K982222 · 1998-07-29

ApplicantSynthes (Usa)
Decision Date1998-07-29
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 1998-07-29 under 510(k) number K982222. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM?

SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM is a medical device that received FDA 510(k) clearance on 1998-07-29. The listed applicant is Synthes (Usa). The 510(k) number is K982222.

When did SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM receive FDA 510(k) clearance?

SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM received FDA 510(k) clearance on 1998-07-29, under 510(k) number K982222.

Who is the listed applicant for SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM?

The FDA 510(k) record lists Synthes (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM?

The FDA product code for SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM is HWC. This falls under the Cardiovascular category.

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Related Devices (Code: HWC)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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